Whole Body Electromyostimulation and Nutritional Therapy for Patients With Esophageal and Bronchial Carcinoma
- Conditions
- Cancer of EsophagusCancer, Lung
- Interventions
- Procedure: whole body electromyostimulation exerciseProcedure: protein-rich nutrition therapy
- Registration Number
- NCT03274349
- Lead Sponsor
- University of Erlangen-Nürnberg Medical School
- Brief Summary
The objective or the trial is to study the influence of a combined therapy involving protein-rich individualized nutritional therapy and highly effective muscle training via personalized whole-body electromyostimulation exercise on muscle mass, muscle functionality, physical capability, fatigue and quality of life in patients with esophageal and bronchial carcinoma in advanced or metastatic stage.
- Detailed Description
Tumor specific and inflammation promoting mediators lead to a loss of appetite, to systemic inflammation processes and to metabolic and hormonal changes including anabolic resistance. Consequences hereof are a decreased food uptake, a deteriorated nutrient utilization and a loss of muscles and/or fat leading to cancer cachexia. In addition, an accelerated muscle wasting can be a side effect of the oncologic therapy promoting cancer cachexia even further. The advancing muscle loss induces diminishing physical capability, a decreased tolerance of oncological therapy, functional losses even reaching loss of independence and a worsened prognosis.
The purpose of this study is to establish an innovative combined therapy involving protein-rich nutritional therapy and highly effective muscle training by personalized whole-body electromyostimulation (WB-EMS) exercise to improve muscle mass, functionality and strength of esophageal and bronchial carcinoma patients in advanced stage. An increase in muscle mass and strength leads to an increase in physical activity, physical capability as well as tolerance to and applicability of tumor therapy. In the course of a 3-months intervention study the efficacy of a combined protein-rich nutritional therapy with an innovative exercise therapy will be documented for patients with esophageal and bronchial carcinoma in advanced or metastatic stage. An effective stopping of the progress of muscle wasting or even increase of muscle mass, strength and function in the patients of the trial would benefit each patient and his family individually, since it could mean a considerable improvement in his quality of life and tolerability of oncological treatment.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 150
- Patients with esophageal and/or bronchial carcinoma in curative or palliative treatment
- Healthy persons or patients under age
- Pregnancy, Lactation
- Psychological disorders, epilepsia, sever neurological disorders
- Participation in other exercise- or nutrition studies within the last 6 months
- Acute cardiovascular disease
- Rheuma
- Intake of anabolic drugs,
- Skin injuries in the area of electrode placements
- Electronic implants (defibrillator, pacemaker)
- Persons in mental hospitals by order of authorities or jurisdiction
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description EMS-group whole body electromyostimulation exercise Group of patients receiving individualized protein-rich nutritional therapy with personalized whole body electromyostimulation exercise, 12 weeks intervention per patient Control protein-rich nutrition therapy Group of patients receiving individualized protein-rich nutritional therapy without exercise, 12 weeks intervention per patient EMS-group protein-rich nutrition therapy Group of patients receiving individualized protein-rich nutritional therapy with personalized whole body electromyostimulation exercise, 12 weeks intervention per patient
- Primary Outcome Measures
Name Time Method Muscle mass maintenance or increase, as assessed by Bioelectrical Impedance Analysis 12 weeks per patient Maintenance or increase of skeletal muscle mass in patients with esophagus or bronchial carcinoma receiving a combined therapy of protein-rich nutrition and WB-EMS, by assessing Bioelectrical Impedance Analysis values.
- Secondary Outcome Measures
Name Time Method Improvement of pain scores, as assessed by Visual Analog Score 12 weeks per patient Clinical improvement by an increase of pain scores in patients with esophagus or bronchial carcinoma receiving a combined therapy of protein-rich nutrition and WB-EMS.
Maintenance or increase in Body Mass Index (BMI) in kg/m^2-analysis (combination of weight in kilograms and height and in meters 12 weeks per patient Maintenance or increase of skeletal muscle mass in patients with esophagus or bronchial carcinoma receiving a combined therapy of protein-rich nutrition and WB-EMS, by assessing BMI in kg/m\^2 (combination of weight in kilograms and height in meters).
Increase in quality of life score by assessing the score points using EORTC-QLQ-C30 questionnaires 12 weeks per patient Clinical improvement by an increase in quality of life in patients with esophagus or bronchial carcinoma receiving a combined therapy of protein-rich nutrition and WB-EMS.
Increase or maintenance of muscle strength, as assessed by hand grip strength measurements (Jamar dynamometry) 12 weeks per patient Clinical improvement by an increase in muscle strength in patients with esophagus or bronchial carcinoma receiving a combined therapy of protein-rich nutrition and WB-EMS.
Improvement of oncological therapy tolerance, as assessed by Common Toxicity Criteria regarding gastrointestinal complaints 12 weeks per patient Clinical improvement oncology therapy tolerance in patients with esophagus or bronchial carcinoma receiving a combined therapy of protein-rich nutrition and WB-EMS.
Improvement of fatigue scores, as assessed by FACIT-Fatigue Score 12 weeks per patient Clinical improvement by an increase of fatigue scores in patients with esophagus or bronchial carcinoma receiving a combined therapy of protein-rich nutrition and WB-EMS.
Trial Locations
- Locations (1)
University Hospital Erlangen, Department of Medicine 1
🇩🇪Erlangen, Bavaria, Germany